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Learning Objectives Explain the importance of the pharmaceutical system in the overall health system Understand and identify the key components of supply chain management Understand and identify the determinants of pharmaceutical system failure Understand and identify the key considerations of ART supply chain management

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Importance of Pharmaceutical Systems Drugs are specialised health commodities Pharmaceuticals are the second highest public health budget expenditure in most countries Drug expenditure accounts for 50-90% of non-personnel health system costs Access to affordable high quality health commodities is central to health care systems Drug availability promotes confidence in health systems Management of pharmaceutical systems is complex

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Role of pharmaceutical systems Uninterrupted availability of pharmaceuticals Affordability of pharmaceuticals Ensuring that safe and efficacious drugs are available in the correct form and condition for the correct indication and at an affordable cost whenever client needs them

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Logistics Cycle The framework through which pharmaceutical systems function Ultimate goal is to meet customer needs All the components of the cycle should be carefully planned, implemented and monitored Emphasis must be placed on creating an enabling environment for effective pharmaceutical management

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Corruption World Bank Definition..behaviour on the part of officials in the public and private sectors, in which they improperly and unlawfully enrich themselves and/or those close to them, or induce others to do so, by misusing the position in which they are placed.

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How the drug industry works Drugs expensive to manufacture but easy to copy R&D very expensive ($800 m/drug*), most new drugs fail To do R&D, companies need incentive IP: Patents for 20 years - market exclusivity but what happens in: –Markets where public has no purchasing power –Diseases that have no profits (malaria) –10% of R&D spending on diseases that cause 90% of global disease burden (* Pharma funded study)

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The Pharmaceutical Controversy Drug companies want to maximize profits Public Health aims to maximize impact Big Pharma argues no profit, no R&D (except publicly funded e.g. vaccines) So how do you reconcile profits and access? TRIPS and Doha Declaration

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Public Health/Pharmaceutical Scale Are rights to IP >, = or < Right to Health? Intellectual PropertyHealth & Life

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Goals of ART Maximum and durable viral suppression –Durability of viral suppression by initial treatment regimen is a determinant of sustainable access to efficacious ART Restoration and preservation of optimal immune function Reduction of morbidity and mortality Improvement of quality of life

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Forecasting & Quantification This must be done prior to commencing an ART program Always consider newness of ART programs –lack of accurate data –Use available data e.g. other programs, demographic, morbidity Careful monitoring of consumption and program performance Need for flexibility as data is gathered from the program

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Logistics Management Information System (LMIS) The need for an information system to manage the supply chain is not an option ARV LMIS should be developed prior to starting an ART program Training of healthcare workers

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Commodity Security Generally ARV drugs are not in full supply However the pharmaceutical system must ensure uninterrupted supply for ALL patients started on ART The system must also have the capacity to accommodate any planned program scale-up Sustainability of ART programs is directly related to the pharmaceutical system capacity

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Conclusions Pharmaceutical policies reach beyond health and touch on areas of trade and industrial policies The global drug gap is due to market and government failures and limited budgets and income in developing countries Governments can turn to outside support for technical assistance when desired Domestic drug production can be a solution to solving the drug gap Policies and practices should be in place to ensure well- functioning pharmaceutical systems

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Speaking about AIDS is a point of pride, not a source of shame. There must be no more sticking heads in the sand, no more embarrassment, no more hiding behind the veil of apathy K. Annan Bangkok 2004